Table 3.
Characteristics of extended half-life (EHL) recombinant factor VIII products, licensed in 2022.
| Product (Brand) | Company | Year of First Licensing | Technology | Cell Line | FVIII | Half-Life (Hours) |
Immunogenicity PTPs (%) |
Immunogenicity PUPs (%) |
Ref. |
|---|---|---|---|---|---|---|---|---|---|
| Efmoroctocog alfa (Elocta, Eloctate) |
Sanofi | 2014 | IgG1-Fc-fusion | HEK | B-domain deleted | 19 (OSA) 20.9 (CSA) |
No inhibitor No anaphylaxis |
31.1 All inhibitors 15.6 HT inhibitors No anaphylaxis |
[66,67,77,78] |
| Rurioctocog alfa pegol (Adynovi, Adynovate) |
Takeda | 2015 | Random PEGylation |
CHO | full-length | 14.3–16 (OSA) |
No inhibitor No anaphylaxis |
19.2 All inhibitors | [63,73,79] |
| Damoctocog alfa pegol (JIVI) |
Bayer | 2018 | Site-specific PEGylation | BHK | B-domain deleted | 19 (OSA) (>12 yo) 15–16 (OSA) (<12 yo) |
No inhibitor 1.5 hypersensibility 3.7 anti-PEG Ab |
NA | [64,72] |
| Turoctocog alfa pegol (N8-GP, Esperoct) |
Novo Nordisk | 2019 | Site-specific glycoPEGylation |
CHO | B-domain truncated | 15.8–19.9 (CSA) (>12 yo) 13.2–14.2 (CSA) (<12 yo) |
0.6 All inhibitors 12.3 anti-PEG Ab (>12 yo) 29.4 anti-PEG Ab (<12 yo) |
29.9 All inhibitors 14.9 HT inhibitors No anaphylaxis |
[65,71,80] |
PTPs, previously treated patients; PUPs, previously untreated patients; FVIII, factor VIII; CHO, Chinese hamster ovary cell line, BHK, baby hamster kidney cell line; HEK, human embryonic kidney; OSA, one-stage clotting assay; CSA, chromogenic substrate assay; Ab, antibody; NA, not available; Ref., references.